DE202011111107U1 - Transcatheter mitral valve prosthesis - Google Patents

Abstract

A delivery system (1124) for delivering a prosthetic heart valve (10; 800) to a patient's heart, the prosthetic heart valve (10; 800) having an anchor (16) with a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the has a prosthetic heart valve (10; 800) on the patient's heart and a commissure post (24; 813) with a commissure flap (812), the delivery system (1124) having a hub shaft (1622) with a slot (1619) for receiving the commissure flap ( 812) of the prosthetic heart valve (10; 800); a bell shaft (1624) which is slidably and concentrically arranged over the hub shaft (1622) to cover the slot (1619) of the hub shaft (1622); anda sleeve (1604) slidably and concentrically disposed over the bell stem (1619) to receive the prosthetic heart valve (10; 800) in the collapsed configuration; the prosthetic heart valve (10; 800) by retracting the sleeve (1604 ) independently expand into engagement with the patient's natural cardiac tissue while the commissure flap (812) is still trapped in the slot (1619) of the hub shaft (1622); and wherein the commissure flap (812) can independently expand out of the slot (1619) by withdrawing the bell shaft (1624) in order to completely release the prosthetic heart valve (10; 800) from the delivery system (1124).

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention. The present invention relates generally to medical devices and, more particularly, to the treatment of valve regurgitation, such as mitral regurgitation, which is also referred to as mitral regurgitation. The use of valve prostheses that are delivered by conventional surgical implantation procedures or by less invasive percutaneous catheter or minimally invasive, transapical procedures are a possible treatment for valve insufficiency.

The heart of vertebrates is divided into four chambers and is equipped with four valves (the mitral, aortic, pulmonary and tricuspid valves) that ensure that blood pumped through the heart flows in a forward direction through the cardiovascular system. The mitral valve of a healthy heart prevents blood from flowing back from the left chamber into the left atrium of the heart and includes two flexible leaflets (anterior and posterior) that close when the left chamber contracts. The leaflets are attached to a fibrous annulus and their free edges are attached to papillary muscles in the left ventricle by subvalvular chordae tendinae to prevent them from prolapsing into the left atrium during contraction of the left ventricle.

Various heart diseases or degenerative changes can cause a malfunction in one of these sections of the mitral valve device, causing the mitral valve to become abnormally narrow or dilated, or to allow blood to escape (i.e., regurgitate) from the left ventricle back into the left atrium. Any such impairment endangers heart failure and can weaken or be life-threatening.

A variety of surgical methods and devices have been developed to treat mitral valve dysfunction, including open heart surgical techniques to replace, repair or reshape the native mitral valve apparatus, and the surgical implantation of various prosthetic devices, such as anuloplasty rings, around the anatomy of the native mitral valve to change. Less invasive transcatheter techniques for delivering mitral valve replacement assemblies have recently been developed. Such techniques generally mount a prosthetic valve in a compressed state on the end of a flexible catheter and advance it through a blood vessel or the patient's body until the valve reaches the implantation site. The valve prosthesis is then expanded to the functional size at the location of the defective native valve.

Although these devices and methods are promising treatments for valve insufficiency, they can be difficult to deliver, expensive to manufacture, or not appropriate for all patients. Therefore, it is desirable to provide improved devices and methods for the treatment of valve insufficiency, such as mitral valve insufficiency. At least some of these tasks are accomplished by the facilities and procedures disclosed below.

2. Description of the technological background. For example, that describes international PCT Patent No. PCT / US2008 / 054410 (published as PCT International Publication No. WO2008 / 103722 ), the disclosure of which is hereby incorporated by reference, a transcatheter mitral valve prosthesis that includes a spring ring, a plurality of sail membranes that are mounted with respect to the ring to allow unidirectional blood flow therethrough, and a plurality of has positioning elements engaging in tissue which are movably mounted and dimensioned with respect to the ring in order to grip the anatomical structure of the heart valve ring, the heart valve leaflets and / or the heart wall. Each of the positioning elements defines respective proximal, intermediate, and distal tissue engagement areas that are cooperatively configured and dimensioned to simultaneously engage different corresponding areas of the tissue of an anatomical structure and may include respective first, second, and third elongate tissue-penetrating elements. The valve prosthesis may also include an apron that is mounted around the valve prosthesis with respect to the spring ring to seal a periphery of the valve prosthesis against backward blood flow.

The international PCT Patent No. PCT / US2009 / 041754 (published as PCT International Publication No. WO2009 / 134701 ), the disclosure of which is hereby incorporated by reference, describes a mitral valve prosthesis assembly having an anchor or an outer support frame with a flared upper end and a tapered portion to conform to the contour of the native mitral valve, and a tissue-based disposable valve mounted therein. The assembly is designed to expand radially outward and in contact with the native cardiac tissue to create compression and further includes tension members that place the leaflet assembly sails in a suitable location on the heart anchor to serve as a prosthetic Chordae Tendineae.

Also known from the prior art are prosthetic mitral valve assemblies that use a claw structure to attach the prosthesis to the heart (see, for example, US patent application publication no. US2007 / 0016286 von Hermann et al., the disclosure of which is hereby incorporated by reference), as well as mitral valve prosthesis assemblies or prosthetic mitral valve assemblies that rely on the use of axial rather than radial clamp forces in order to enable the prosthesis to be self-positioned and self-anchored in relation to the native anatomical structure .

Another technique that has been proposed as a treatment for mitral valve regurgitation is the surgical bow-tie technique that has recently been used in a minimally invasive catheter-based treatment that uses an implant to clamp the valve leaflets together. This process is more fully disclosed in the scientific and patent literature, such as that in the U.S. Patent No. 6,629,534 by St. Goar et al., the entire contents of which are hereby incorporated by reference.

Other relevant publications include U.S. Patent Publication No. 2011/0015731 by Carpentier et al. a.

BRIEF SUMMARY OF THE INVENTION

The present invention relates generally to medical devices and, more particularly, to prosthetic valves used to treat mitral regurgitation. While the present disclosure focuses on using a valve prosthesis to treat mitral valve regurgitation, this is not intended to be a limitation. The prosthetic valves disclosed herein can also be used to treat other body valves, including other heart valves or venous valves. Exemplary heart valves include the aortic valve, the tricuspid valve, or the pulmonary valve.

In the embodiments of the present subject matter, transcatheter mitral valve prostheses and transcatheter systems for inserting them are provided. In certain embodiments, the mitral valve prosthesis includes a tissue-like, disposable prosthetic valve structure having a plurality of leaflets attached in a self-expanding or expandable anchoring portion (ie, frame) that has a geometry that expands in a low-profile atrial apron area, an anular area that dimensions is, generally to conform to a native mitral valve annulus, a ventricular apron area that displaces or displaces the native mitral valve leaflets and includes a plurality of sail connections that extend into the sub-anular ventricular space (ie, in the direction of blood flow through the prosthesis) and are set up to optimize the efficiency of the prosthetic valve structure and the load distribution on its sails. The anchoring section can also be asymmetrical along its longitudinal axis in preferred embodiments, with the antrial apron region, the anular region and / or the ventricular apron region having differently designed anterior and posterior aspects, in order to enable a close mapping of the asymmetrical contours and features of a typical native mitral valve apparatus . This asymmetry may result inherently from the structural structure of the anchoring section, as discussed below, and / or as a result of the molding or molding steps used during the manufacturing process.

In preferred embodiments, the prosthetic valve structure can comprise a bicuspid or tricuspid valve in order to partially simplify the manufacture of the mitral valve prosthesis, but as can be seen directly by the person skilled in the art, other configurations are possible. The sails can be made from a single piece or from several pieces of standard biological prosthesis material, such as, for example, cryopreserved or chemically preserved pericardium (for example beef, horse, pork, goat, kangaroo) or suitable synthetic standard prosthesis materials (for example fiber-reinforced) Matrix materials) that are well known in the art and that can be sewn or otherwise attached to the anchor to form the valve leaflets in a suitable standard manner.

In order to optimize the efficiency of the prosthetic valve and the load distribution on the prosthetic sails, the commissures generally extend axially cantilevered downstream into the subanular space and are able to bend radially and laterally along their axial length to accommodate the distribute forces related to blood flow through the prosthetic valve structure. In some embodiments, the commissures (when the mitral valve prosthesis is in an expanding state) define an approximately truncated cone-like opening that tapers along the forward direction of blood flow to help close the prosthetic valve structure during contraction of the ventricle. To efficiency and To further optimize load distribution on the sails, the commissures can be shaped and dimensioned to provide the attachment of the sails along arcuate hems and can also be selectively flexible at different points or zones along their axial length, for example by adding or removing reinforcing struts or by changing the thickness of the commissures in selected areas.

The anchoring portion of the mitral valve prosthesis is preferably made from a single piece of metallic material that has been cut out to allow the mitral valve prosthesis to be compressed into a compact, generally tubular delivery configuration and to be expanded into the insert configuration further described herein. In self-expanding embodiments, the anchoring portion of the mitral prosthesis can be made from a shape memory alloy (SMA), such as the nickel-titanium alloy nitinol, and in expandable embodiments, the anchoring portion can be made from any metal material, such as a chrome alloy or stainless steel be suitable for implantation in the body. In some embodiments, the metal material may have a single thickness over the entire anchoring section and in others it may vary in thickness to allow variations in the radial force exerted by the anchoring section in certain areas thereof, to increase the flexibility of the anchoring section increase or decrease in certain areas and / or control the compression process in preparation for insertion and the expansion process during insertion.

When inserted, the atrial apron area of the mitral valve prosthesis generally extends radially outward to lie flat against and cover the native mitral valve annulus and to anchor the mitral valve prosthesis to at least a portion of the adjacent atrial surface of the heart. The atrial apron area has a low axial. Profile (which extends only slightly into the atrium) to minimize potentially thrombotic turbulence in blood flow and, in preferred embodiments, may be covered with standard biological or synthetic prosthetic materials of the type described above to seal the atrial apron area against the atrial surface and conduct atrial To allow blood through the mitral valve prosthesis. In some embodiments, the atrial skirt region also includes atrial barbs or tines to facilitate anchoring the inserted prosthesis to the atrial heart surface. In order to facilitate the alignment and adjustment of the mitral valve prosthesis in the native mitral valve during insertion, particularly in embodiments in which the anchoring section is asymmetrical in the longitudinal direction, the atrial apron region of the anchoring section of the mitral valve prosthesis can preferably also have an alignment structure that is different from the rest of the atrial apron region can be distinguishable (such as by angiography, computed tomography, etc.) and can thus be used as an orientation aid during insertion. Most preferably, the alignment structure may include an extension of the anterior aspect of the atrial apron area that is configured to expand radially to accommodate the aortic root portion of the atrial surface.

The annular area of the mitral valve prosthesis is dimensioned as noted above, in order to generally adapt and anchor itself to a native mitral valve annulus when inserted. In preferred embodiments, the anular area employed may define a generally D-shaped annulus suitable for conforming to the contours of a typical native mitral valve, and may be covered with a standard biological or synthetic prosthetic material of the type described above to oppose the anular area to seal the native mitral valve annulus.

The ventricular apron area generally expands radially outward against the native mitral valve when inserted into the ventricular space, but not to the extent that it blocks the left ventricular outflow tract or touches the ventricular wall. In order to anchor the mitral valve prosthesis in the ventricular space on the displaced or relocated native sails, the maximum radial offset of the fully inserted ventricular apron area is selected so that it is slightly larger than the circumference of the native mitral valve. In preferred embodiments, the ventricular apron area also includes ventricular and / or native sail barbs or tines in order to further anchor the inserted prosthesis to it. The ventricular apron area is particularly preferably asymmetrical and its prongs comprise two trigonal anchoring tabs which are arranged in the anterior aspect of the ventricular shooter area for anchoring to the Trigona Fibrosa on each side of the anterior sail of the native mitral valve, and a posterior ventricular anchoring tab in which posterior aspect of the ventricular apron area is arranged for anchoring over the posterior sail of the native mitral valve. With these tabs hang further down insertion control areas described in more detail together.

The ventricular apron area may, in some embodiments, also be covered with a standard biological or synthetic prosthetic material of the type described above to seal the ventricular apron area against the displaced native sails and thereby direct ventricular blood (during ventricular contraction) towards the prosthetic valve structure. to aid in their occlusion during contraction of the ventricle.

The combined 3-zone anchoring of the mitral valve prosthesis against the atrial surface, the native valve annulus and the displaced native sails (in preferred embodiments supplemented by a 4th anchoring zone from the trigonal and posterior ventricular anchoring) in the ventricular space prevent migration or removal of the prosthesis from within the native valve annulus during contraction of the atrium or chamber, and reduce the anchorage pressure that must be applied in any of the given anchorage zones compared to, or in any combination of, a prosthesis that is only anchored in a single anchorage zone four anchoring zones. The consequent reduction in the radial force that must be exerted on the native structures in each zone minimizes the risk of obstruction or collision of the nearby aortic valve or root caused by the relocation of the native mitral valve apparatus. The combined 3 or 4 zone anchoring of the mitral valve prosthesis, as described below, also facilitates the positioning and / or repositioning of the mitral valve prosthesis.

To insert the mitral valve prosthesis into the native mitral valve apparatus, the prosthesis is first compressed and loaded into a suitably adapted conventional catheter delivery system of the type known to those skilled in the art. In order to facilitate later insertion, the commissures and the associated prosthetic valve structure of the prosthesis are preferably captured or received in an inner lumen of the catheter delivery system and the remaining sections of the anchoring area are received in a secondary outer lumen of the catheter delivery system. The loaded mitral valve prosthesis can then be inserted in its compact form into the left atrium of the heart using a conventional catheter delivery system (typically either transseptal or transapical). The prosthesis is detachably attached to the catheter delivery system via its commissures or connections and is shielded by its (preferably two-lumen) delivery sleeve during passage into the atrial space. Once the prosthesis has been inserted into the left antechamber, the delivery sleeve of the catheter delivery system is withdrawn as described below to allow expansion of various areas of the prosthesis. Of course, in self-expanding embodiments, the prosthesis will expand spontaneously when the delivery sleeve is withdrawn, and in expandable designs, a catheter inflation structure, such as a balloon, is required to effect the expansion.

The insertion of the mitral valve prosthesis can be different depending on the features of the particular embodiment of the prosthesis to be used. For example, in asymmetric embodiments that have trigonal anchoring tabs and a posterior ventricular anchoring tab in the ventricular apron area (as well as preferably an alignment structure in the atrial area), these tabs may preferably be used prior to insertion of the remaining portions of the ventricular apron areas to anchor of these tabs on the native Trigona fibrosa or the posterior sail.

The first general insertion step allows the atrial apron area of the mitral valve prosthesis to expand (or be balloon expanded following withdrawal of the corresponding portion of the delivery device) in the left atrium of the heart and the expanded atrial as the corresponding portion of the delivery device is withdrawn The apron area is then positioned over the atrial surface of the native mitral valve and anchored to at least a portion of the adjacent atrial surface of the heart. In preferred embodiments in which the atrial apron region has an alignment structure, this first general deployment step can be further broken down into two sub-steps, with the catheter delivery sleeve initially being withdrawn only to allow expansion of the alignment structure (so that it can be visualized for manipulation purposes) the delivery system so that the mitral valve prosthesis can be aligned in a desired position), and then, once alignment of the prosthesis appears satisfactory, it is further withdrawn to expand, position, and anchor the remaining portions of the atrial apron area to enable. In embodiments in which the alignment structure has an extension of the anterior aspect of the atrial apron region, such includes one initial alignment is a rotation and / or alignment of the alignment structure so that it is located adjacent to the aortic root and between the trigona fibrosa of the native anterior sail.

Next, the annular portion of the prosthesis is allowed to expand by further withdrawing the catheter delivery sleeve to engage the native mitral valve annulus (i.e., touching the native valve annulus over at least a majority thereof) to provide a second anchoring zone and a suitable opening for it generate blood flow through the prosthetic valve structure.

Then, in embodiments having trigonal anchoring tabs and a posterior ventricular anchoring tab in the ventricular apron area, the catheter delivery sleeve is further retracted to allow the tabs to expand while covering the rest of the prosthesis ventricular apron area, including the insertion control areas of the tabs stay. With the insertion control areas now remaining in the delivery system and anchored to the atrial apron area on the atrial surface, the tabs stand radially outward to facilitate engagement with the corresponding features of the native mitral valve. The posterior ventricular anchor tab is aligned with the center of the posterior sail of the mitral valve, where there are no chordae attachments with the posterior sail, and is passed over the posterior sail to sit between the posterior sail and the ventricular wall. The two trigonal anchoring tabs are positioned on either side of the anterior sail with their heads positioned at the Trigona Fibrosa. A slight rotation and realignment of the prosthesis can take place at this time.

Once the assembly is properly positioned and the tabs aligned, the catheter delivery sleeve can be retracted further to allow expansion of the remaining portions of the ventricular apron area to secure the prosthesis in the mitral device and seal the mitral annulus. Completely retracting the outer catheter delivery sleeve exposes the ventricular apron area and allows the anchoring tabs to approach their anchoring site. As the prosthesis expands, the trigonal tabs anchor to the Trigona fibrosa, capture the native anterior sail and chordae between the tabs and the anterior surface of the prosthetic valve assembly, and the posterior ventricular tab anchors between the ventricular wall and posterior sails and captures insert the posterior sail between the posterior anchor tab and the posterior surface of the prosthetic valve assembly. The remaining portions of the ventricular apron area expand outward against the native mitral valve leaflets and adjacent anatomy, creating a sealing funnel within the native leaflets and displacing the native leaflets by the prosthetic commissures to avoid obstructing the prosthetic valve function. With the commissures of the prosthesis still included in the delivery system, very small adjustments can still be made to ensure accurate positioning, anchoring and sealing.

In embodiments that have no trigonal anchoring tabs and no posterior ventricular anchoring tab in the ventricular apron area, withdrawal of the catheter delivery sleeve from the ventricular apron area can, of course, be done in one step after the atrial apron and anular areas of the prosthesis have been pre-anchored to it to enable the ventricular apron area of the prosthesis to expand against the native mitral valve and additionally to anchor the prosthesis to the displaced native sails in the ventricular space. Optionally, the mitral valve prosthesis, which is still releasably attached to the catheter delivery system via its commissures at this time, can be guided a little further downstream into the ventricular space in order to generate a greater seating force between the atrial apron area and the atrial surface of the heart and also hold for provide any ventricular and / or native sail barbs or tines that may be present in the ventricular apron area. In embodiments in which the atrial apron region, the annular region and / or the ventricular apron region are covered with a suitable biological or synthetic prosthesis material, a seal can also be formed between the respective regions of the prosthesis and the associated zone of the native mitral valve apparatus.

Once satisfactory prosthesis positioning is achieved, the commissures are eventually released from the catheter delivery system, allowing the catheter delivery system to be withdrawn and leaving the mitral valve prosthesis in place as a functional replacement for the native mitral valve apparatus. When the commissures are released, the prosthesis may also undergo a final step of shortening and setting because any remaining pressure exerted by the delivery system is released. The atrial apron area can spring back slightly as a result of this pressure release, which pulls the prosthesis slightly further up into the left atrium and thereby the ventricular apron area including any related barbs, tines or tabs. In embodiments that have trigonal anchoring tabs, their placement pulls the received anterior sail tightly against the prosthesis, thereby avoiding or minimizing obstruction of the left ventricular outflow tract (LVOT) and placing the ventricular apron area firmly in the annulus to prevent paravalvular leakage. Once the final insertion is complete, the delivery system is withdrawn and removed.

One method of anchoring a prosthetic valve in a patient's heart may be to provide the prosthetic valve, the prosthetic valve having an anchor with an atrial skirt, an anular region, a ventricular skirt, and a plurality of valve leaflets, the anchor having a collapsed configuration for delivery to the heart and an expanded configuration for anchoring to the heart, and positioning the prosthetic valve in the patient's heart. The method may also include expanding the atrial apron radially outward to overlie an overlying surface of the patient's native mitral valve, anchoring the atrial apron to a portion of the atrium, and radially expanding the anular portion of the anchoring to accommodate the adapt and engage with the native mitral valve annulus. The method may also include radially expanding the ventricular skirt, thereby displacing the native mitral valve leaflets radially outward.

At least a portion of the prosthetic valve can be covered with tissue or a synthetic material. Positioning the prosthetic valve may include transseptally delivering the prosthetic valve from the right atrium to the left atrium of the heart, or transapically feeding the prosthetic valve from an area outside the heart to the left ventricle of the heart.

The expansion of the atrial apron can include a sliding movement of a retention sleeve away from the atrial apron, thereby allowing its radial expansion. The atrial apron can expand itself when the retention sleeve is removed from it. The method may further include applying a force to the prosthetic valve to ensure that the atrial skirt engages the top surface of the mitral valve. The atrial apron may have a plurality of barbs and the expansion of the atrial apron may include anchoring the barbs in the upper surface of the mitral valve. Expanding the atrial apron may include sealing the atrial apron against the top surface of the native mitral valve.

Radially expanding the annular region may include sliding a retention sleeve away from the annular region, thereby enabling its radial expansion. The annular area can expand itself when the retention sleeve is removed therefrom. Radially expanding the anular area may include asymmetrically expanding the anular area such that an anterior portion of the anular area is substantially flat and a posterior portion of the anular area is cylindrically shaped.

The ventricular apron may further include a trigonal anchoring tab on an anterior portion of the ventricular apron, and radially expanding the ventricular apron may include anchoring the trigonal anchoring tab on a first Trigona Fibrosa on a first side of the anterior sail of the native mitral valve. The native anterior sail and adjacent Chordae Tendineae can be captured or received between the trigonal anchor tab and an anterior surface of the anchor. The ventricular apron may further include a second trigonal anchoring tab on the anterior portion of the ventricular apron, wherein radially expanding the ventricular apron may include anchoring the second trigonal anchoring tab to a second Trigona fibrosa that is opposite the first Trigona fibrosa. The native anterior sail and adjacent Chordae Tendineae can be placed between the second trigonal anchor tab and an anterior surface of the anchor. The ventricular apron may further include a posterior ventricular anchoring tab on a posterior portion of the ventricular apron. Radially expanding the ventricular skirt may include anchoring the posterior ventricular anchor tab over a posterior sail of the native mitral valve to sit between the posterior sail and a ventricular wall of the heart. Radially expanding the ventricular skirt may include sliding a retention sleeve away from the ventricular skirt, thereby allowing its radial expansion. The ventricular apron can expand itself when the retention sleeve is removed from it.

The ventricular apron may have a plurality of barbs, and expanding the ventricular apron may include anchoring the barbs in cardiac tissue. The prosthetic valve can be a variety of prosthetic Having valve leaflets and a radial expansion of the ventricular apron can include shifting the native mitral valve leaflets radially outward, thereby preventing a collision of the native mitral valve leaflets with the prosthetic valve leaflets. Radially expanding the ventricular skirt can include moving the native mitral valve leaflets radially outward without touching a ventricular wall and without obstructing a left ventricular outflow tract. Radially expanding the ventricular apron may include asymmetrically expanding the ventricular apron such that an anterior portion of the ventricular apron is substantially flat and a posterior portion of the ventricular apron is cylindrical.

The atrial apron may include an alignment member and the method may include aligning the alignment member relative to the patient's valve. The valve may have a mitral valve and alignment may include aligning the alignment element with an aortic root and arranging the alignment between two Trigona Fibrosa of an anterior sail of the mitral valve. Alignment can include rotating the prosthetic valve. The prosthetic valve may have a plurality of prosthetic leaflets coupled to one or more commissures, and the method may include releasing the commissures from a delivery catheter. The prosthetic valve can have a tricuspid sail construction.

The prosthetic valve may have an open configuration in which the prosthetic valve leaflets are located away from each other and a closed configuration in which the prosthetic valve leaflets are engaged with each other. Blood flows freely through the prosthetic valve in the open configuration and a retrograde blood flow across the prosthetic valve is essentially prevented in the closed configuration. The method may include reducing or eliminating mitral regurgitation. The prosthetic valve may have a therapeutic agent, and the method may include eluting the therapeutic agent from the prosthetic valve into adjacent tissue.

A prosthetic heart valve may have anchoring with an atrial apron, an anular area, and a ventricular apron. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic heart valve to a patient's heart. The prosthetic valve may also include a plurality of prosthetic valve leaflets, each of the leaflets having a first end and a free end, the first end coupled to the anchor, and the free end opposite the first end. The prosthetic heart valve may have an open configuration in which the free ends of the prosthetic valve leaflets are spaced apart from one another to allow antegrade blood flow past them, and a closed configuration in which the free ends of the prosthetic valve leaflets are engaged with each other and in Essentially preventing a retrograde blood flow past them.

At least a portion of the atrial apron can be covered with tissue or a synthetic material. Coupled to itself, the atrial apron can have a plurality of barbs, the plurality of barbs being adapted to anchor the atrial apron in an upper surface of the patient's mitral valve. The atrial apron can have a collapsed configuration and an expanded configuration. The collapsed configuration may be adapted for delivery to the patient's heart, and the expanded configuration may be radially expanded relative to the collapsed configuration and adapted to overlie an overlying surface of the patient's native mitral valve, thereby securing the atrial skirt to one Section of the atrium is anchored. The atrial apron can expand from the collapsed configuration to the radially expanded configuration even if it is not retained. The atrial apron can have one or more radiopaque markers. The atrial apron can have a plurality of axially aligned struts which are connected to one another by a connecting element, thereby forming a series of vertices and depressions. Some of the apices and valleys may extend axially outward than the rest of the atrial skirt, thereby forming an alignment element.

At least a portion of the annular area may be covered with tissue or a synthetic material. The annular area may have a collapsed configuration and an expanded configuration. The collapsed configuration can be adapted for delivery to a patient's heart, and the expanded configuration can be radially expanded and adapted relative to the collapsed configuration to accommodate and engage the native mitral valve annulus. The annular area can expand from the collapsed configuration to the expanded configuration itself if it is not retained. The anular region may have an asymmetrical D-shaped cross-section, which has a substantially flat anterior section and a cylindrically shaped posterior section. The anular region can have a plurality of axially aligned struts which are connected to one another by a connecting element, as a result of which a series of vertices and depressions are formed. One or more axially aligned struts may have one or more suture holes extending therethrough, the suture holes being sized to receive a seam.

At least a portion of the ventricular apron can be covered with tissue or a synthetic material. The ventricular apron can have an asymmetrical D-shaped cross-section, which has a substantially flat anterior section and a cylindrical shaped posterior section. The ventricular apron can have a collapsed configuration and an expanded configuration. The collapsed configuration may be adapted for delivery to the patient's heart, and the expanded configuration may be radially expanded and adapted relative to the collapsed configuration to radially displace the native mitral valve leaflets. The ventricular apron can expand from the collapsed configuration to the expanded configuration itself if it is not retained.

The ventricular apron may further include a trigonal anchoring tab that is disposed on an anterior portion of the ventricular apron. The trigonal anchoring tab can be adapted to be anchored to a first Trigona Fibrosa on a first side of an anterior sail of the patient's mitral valve. Thus, the anterior sail and adjacent Chordae Tendineae can be captured between the trigonal anchor tab and an anterior surface of the anchor. The ventricular skirt may also have a second trigonal anchoring tab that may be located on the anterior portion of the ventricular skirt. The second trigonal anchoring tab can be adapted to be anchored to a second Trigona fibrosa that is opposite the first Trigona fibrosa so that the anterior sail and adjacent chordae tendinae are received between the second trigonal anchoring tab and the anterior surface of the anchoring. The ventricular apron may further include a posterior ventricular anchoring tab disposed on a posterior portion of the ventricular apron. The posterior ventricular anchor tab may be adapted to anchor over a posterior sail of the patient's mitral valve so that the posterior ventricular anchor tab sits between the posterior sail and a ventricular wall of the patient's heart. The ventricular apron can also have a plurality of barbs coupled to it, which can be adapted to anchor the ventricular apron in the heart tissue. The ventricular skirt may have a plurality of struts connected together by a connector, thereby forming a series of apexes and valleys. One or more struts may have one or more suture holes extending therethrough, the suture holes being sized to receive a seam.

The large number of prosthetic valve leaflets can have a tricuspid sail construction. At least a portion of the one or more prosthetic valve leaflets may include tissue or a synthetic material. One or more of the plurality of prosthetic valve leaflets may be disposed over one or more commissure posts or struts that are preset radially inward relative to the ventricular skirt. The one or more commissure posts or struts may have one or more through-holes that may be sized to receive a seam. The one or more prosthetic valve leaflets can be coupled to a commissure post or strut, which have a commissure tab that is adapted to releasably engage the commissure post or strut with a feed device.

The prosthetic heart valve may further include an alignment element that is coupled to an anterior portion of the anchor. The alignment element can be adapted to be aligned with an aortic root of the heart by the patient and to be arranged between two Trigona Fibrosa of an anterior sail of the patient's mitral valve. The alignment element can be coupled to the atrial skirt. The prosthetic heart valve can also have a therapeutic agent associated with it that is adapted to be eluted in a controlled manner.

In yet another aspect of the present invention, a delivery system for delivering a prosthetic heart valve to a patient's heart has a hub shaft. The delivery system may have an inner guidewire shaft with a lumen extending therethrough and adapted to slidably receive a guidewire, wherein the hub shaft may be concentrically disposed over the inner guidewire shaft. The delivery system also has a bell shaft which is slidably and concentrically arranged over the hub shaft and a sleeve which is slidably and concentrically arranged over the bell shaft. The delivery system may have a handle near a proximal end of the delivery system. The handle can Have actuating mechanism which is adapted to advance and retract the bell shaft and the sleeve.

The system may also include the prosthetic heart valve, which may be received in the sleeve in a radially collapsed configuration. The prosthetic heart valve can be anchored with an atrial apron, an anular region and a ventricular apron. The prosthetic valve can also have a variety of prosthetic valve leaflets. Each of the sails can have a first end and a free end. The first end may be coupled to the anchor and the free end may be opposite the first end. The prosthetic heart valve may have an open configuration in which the free ends of the prosthetic valve leaflets are spaced apart to allow antegrade blood flow therethrough. The valve may have a closed configuration in which the free ends of the prosthetic valve leaflets engage each other and substantially prevent retrograde blood flow past them.

Proximal withdrawal of the sleeve relative to the bell stem can remove a restriction from the prosthetic heart valve, thereby allowing the prosthetic heart valve to expand into engagement with the patient's native heart tissue itself. The prosthetic heart valve can be releasably coupled to the hub shaft and proximal retraction of the bell shaft relative to the hub shaft can release the prosthetic heart valve therefrom. The actuating mechanism can have a rotatable wheel. The system may also include a tissue-penetrating distal tip coupled to the hub shaft. The distal tip penetrating tissue can be adapted to pass through an incision in the heart of the patient and expand it. The system may also include a pin lock mechanism that is releasably coupled to the handle. The pin locking mechanism can restrict proximal withdrawal of the sleeve.

These and other embodiments are described in more detail in the following description with reference to the attached drawing figures.

Figure list

• In the drawings, the same reference numerals designate the same or similar steps or components.
• 1 is a schematic representation of the left ventricle showing arrows showing blood flow during systole.
• 2nd Figure 3 is a schematic illustration of the left ventricle having prolapsed sails in the mitral valve.
• 3rd is a schematic illustration of a heart in a patient suffering from cardiomyopathy or myocardial disease, in which the heart is dilated or enlarged and the sails do not meet.
• 3A shows a normal closure of the sails.
• 3B shows an abnormal occlusion in the dilated heart.
• 4th illustrates mitral valve regurgitation in the left ventricle that has impaired papillary muscles.
• The 5A-5B illustrate the mitral valve.
• 6 illustrates a partial cross-sectional view of an exemplary prosthetic mitral valve from below.
• 7 is a perspective view of the anchoring portion of the prosthetic mitral valve shown in FIG 6 you can see.
• 8A is a perspective view of a prosthetic mitral valve.
• 8B is a top view from the atrium of the prosthetic valve 8A ,
• 9A illustrates a perspective view of the prosthetic valve 8A from the forecourt.
• 9B illustrates a perspective view of the prosthetic valve 8A from the ventricle.
• 10th illustrates the prosthetic valve 8A uncovered and unrolled as a flat structure.
• 11 is a side view of a delivery device for implantation of a prosthetic valve.
• 12th Figure 12 is an exploded perspective view of a proximal portion of the delivery device 11 .
• 13 Figure 12 is an exploded perspective view of a distal portion of the delivery device 11 .
• 14 Figure 12 is a cross section of a proximal portion of the delivery device 11 .
• The 15A-15C are cross-sectional views of a distal portion of the delivery device 11 .
• 16 is a side view of another exemplary embodiment of a delivery device for implantation of a prosthetic valve.
• 17th is a perspective view of the feeder 16 .
• 18th is an exploded perspective view of the feeder of 16 .
• The 19A-19B are side views of the feeder 16 during different stages of an operation.
• 20th illustrates a distal portion of the delivery device 16 that is adapted to engage a portion of a prosthetic valve.
• 21 illustrates engagement of the feeder 16 with the prosthetic valve 8A .
• The 22A-22G illustrate an exemplary method for transapical delivery of a prosthetic mitral valve.
• The 23A-23G illustrate an exemplary method for transseptal delivery of a prosthetic mitral valve.
• 24th illustrates a prosthetic mitral valve implanted in the mitral space.
• 25th illustrates a bottom view of a mitral valve implanted in the mitral space, looking up from the left ventricle.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed device, delivery system and method will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.

Heart anatomy. The left chamber LV of a normal heart H in systole is in 1 illustrated. The left chamber LV contracts and blood flows outward through the aortic valve in the direction of the arrows AV which is a tricuspid valve. A backflow of blood or "regurgitation" through the mitral valve MV is prevented because the mitral valve is designed as a "check valve" that prevents backflow if the pressure in the left ventricle is higher than that in the left atrium LA . The mitral valve MV includes a couple of sails that have free edges FE have, which meet evenly in order to, as in 1 illustrated to close. The opposite ends of the sails LF are attached to the surrounding heart structure along an anular area referred to as the annulus AN. The free edges of the sails LF are on the lower sections of the left chamber LV via Chordae Tendineae CT (also referred to herein as Chordae), which include a plurality of branched bands that extend across the lower surfaces of each of the valve leaflets LF are secured. The chordae CT are again on the papillary muscles PM attached, extending from the lower sections of the left ventricle and the interventricular septum IVS extend upwards.

Now on the 2nd to 4th Referring to this, a number of structural damage to the heart can cause mitral regurgitation. Cracked chordae RCT , as in 2nd shown can cause a flap sail LF2 prolapses because an inappropriate tension is transmitted to the sails via the Chordae. While the other sail LF1 maintaining a normal profile, the two valve leaflets do not meet properly and leakage occurs from the left chamber LV in the left atrium LA as shown by the arrow.

Regurgitation also occurs in patients who have cardiomyopathy, in which the heart is enlarged and the increased size prevents the valve leaflets LF , as in 3rd shown to meet properly. The enlargement of the heart causes the mitral annulus to enlarge, which it does to the free edges FE makes it impossible to meet during a systole. The free edges of the anterior and posterior sails usually meet along a line of contour C, as in 3A shown, one on top of the other, but a significant gap G can remain in patients suffering from cardiomyopathy, as in 3B shown.

Mitral valve regurgitation can also occur in patients who suffer from ischemic heart disease where the function of the papillary muscles PM is disabled, as in 4th illustrated. While the left chamber LV contracted in a systole, the papillary muscles contract PM not sufficient to achieve a correct closure. As illustrated, the flaps then prolapse LF1 and LF2 . Another leak occurs from the left chamber LV to the left atrium LA on as shown by the arrow.

5A illustrates the anatomy of a mitral valve MV more clearly that a bicuspid valve with an anterior side ANT and a posterior side POST OFFICE is. The flap closes an anterior (aortic) sail AL and a posterior (mural) sail PL a. Chordae tendineae CT couple the Flap sail AL , PL with the anterolateral papillary muscle ALPM and posteromedial papillary muscle PMPM . The flap sail AL , PL meet along a line known as the anterolateral commissur ALC and posteromedial commissur PMC Reference is made. The annulus AT circumscribes the valve leaflets and two areas that adjoin an anterior section of the annulus on opposite sides of the anterior sail is called the trigonum fibrosum cordis sinistrum or left trigona fibrosa LFT and also as Trigonum fibrosum cordis dextrum or right Trigona Fibrosa RFT Referred. These areas are generally indicated by the solid triangles. 5B illustrates the left and right Trigona Fibrosa LFT , RFT more clear.

While various surgical techniques have been proposed as well as implantable devices and appear to be promising treatments for mitral regurgitation, surgical approaches may require a lengthy recovery period and implantable devices have variable clinical results. Therefore, there continues to be a need for improved facilities and methods for treating mitral regurgation. Although the embodiments disclosed herein are directed to an implantable mitral prosthetic valve for treating mitral regurgation, those skilled in the art will recognize that this is not intended to be limiting and the device and method disclosed herein can also be used to manipulate other heart valves, such as For example, to treat the tricuspid valve, aortic valve, pulmonary valve etc. as well as other valves in the body, such as venous valves.

Prosthetic valve. Prosthetic valves were surgically implanted in the heart as a treatment for mitral regurgitation. Some of these valves were animal-derived valves, such as porcine valves, and others were prosthetic mechanical valves with or without covering tissue. In the recent past, minimally invasive catheter technology has been used to deliver prosthetic valves to the heart. These valves typically include an anchor for securing the valve to the patient's heart and a valve mechanism, either a mechanical valve, an animal tissue valve, or combinations thereof. Once implanted, the prosthetic valve takes on the role of the improperly working native valve, thereby reducing or eliminating valve insufficiency. Although some of these flaps look promising, there is still a need for improved flaps. The following exemplarily discloses embodiments of a prosthetic valve, a prosthetic valve delivery system, and methods for supplying the valve that address some of the challenges associated with existing prosthetic valves.

Now referring to the 6-7 include exemplary embodiments of a mitral valve prosthesis, generally designated by the reference numeral 10th is characterized by a tricuspid tissue-like prosthetic disposable valve structure 12th with sails 14 that are in a self-expanding or expandable anchoring section 16 are attached, which has a geometry that is in the atrial apron region of small cross-section 18th , anular area 20th , ventricular apron area 22 and a variety of commissures 24th (also referred to herein as commissure posts) that extend axially downstream like a krak arm into the sub-annular space that passes through the ventricular apron area 22 is defined. 6 shows a partial cross-section of the valve looking up towards the right atrium 10th from the patient's left chamber. The atrial apron area 18th is on a lower section of the right atrium 19th anchored. The flap sail 14 have an open position (not illustrated) and one in 6 illustrated closed position. The sails are in the open position 14 stored away from each other to allow blood flow past them, and the sails are in the closed position 14 engaged with each other to close the valve and prevent declining blood flow past it. The valve commissures 24th can be set up to effect the prosthetic valve structure 12th and the load distribution on the sails 14 by providing the attachment of the sails 14 along arched hems 28 (best in 7 to see) and to optimize it through targeted flexibility at different points or zones along their axial length by adding / removing reinforcing struts.

7 shows a perspective view of the anchoring portion 16 the flap 10th which has been formed from a series of interconnected struts. The atrial apron area 18th forms an annular flange portion on the anchor to help secure an upper portion of the prosthetic valve in the atrium and the anular portion 20th is a cylindrical area for anchoring the valve along the native valve annulus. The ventricular apron area 22 is similarly cylindrical in shape and aids in anchoring a lower portion of the valve in the patient's left chamber. Any portion or all of the anchorage may be with tissue such as pericardium or others disclosed herein Tissues can be covered, or a synthetic material such as Dacron or ePTFE can be used to cover the anchor. The cover helps seal the anchor to the native valve and this helps direct blood into and through the prosthetic valve, rather than around the valve. In some embodiments, the anchor may remain uncovered. The prosthetic valve has an expanded configuration and a collapsed configuration. The collapsed configuration has a cylindrical shape of small cross-section / profile suitable for mounting on a delivery system and the delivery is preferably carried out either transluminally on a catheter or transapically through the heart wall. The expanded configuration (as illustrated) allows the prosthetic valve to be anchored in a desired position.

8A illustrates a perspective view of a preferred embodiment of a prosthetic mitral valve with the optional covers removed to allow the anchoring struts to be seen. 8B illustrates a top view of the prosthetic valve 8A looking down into the chamber from the atrium. The flap 800 includes an asymmetrically expanded anchoring section with a D-shaped cross section. As shown, the anchor portion generally includes an anterior one 802 and a posterior 804 Aspect along the longitudinal axis, just like an atrial 806 , an anular 808 and a ventricular area 810 which is generally the atrial apron 18th , the annular area 20th and ventricular apron area 23 the one in the top 6-7 described embodiment correspond. Commissures (also referred to herein as commissory posts) 813 generally correspond to the sails 14 the embodiment in the 6-7 . The prosthetic valve 800 a collapsed configuration has an expanded configuration. The collapsed configuration is adapted for loading on a shaft, such as a delivery catheter for transluminal delivery to the heart or on a shaft for transapical delivery through the heart wall. The radially expanded configuration is adapted to anchor the valve to the patient's native heart adjacent to the damaged valve. To allow the flap to expand from the collapsed configuration to the expanded configuration, the anchoring portion of the flap can be made of a self-expanding material such as a nickel-titanium alloy such as Nitinol, or it can also be made of tempered stainless spring steel or a resilient polymer. In yet other embodiments, the anchor may be expandable with an expandable element, such as a balloon. In preferred embodiments, the anchor is made by laser cutting, eroding (EDM) or photochemically etching a tube. The anchorage can also be produced by photochemically etching a flat sheet of material, which is then rolled up with the opposite ends welded together.

The atrial apron section 816 forms a flange area that helps anchor the prosthetic valve to the atrium above the mitral valve. The atrial skirt includes a plurality of triangular fingers that extend radially outward from the anchor to form the flange. The posterior section 804 the atrial apron 816 is generally round or circular while a section of the anterior part 802 the atrial apron 816 is flat. As a result, the atrial skirt region preferably has a D-shaped cross section. This allows the prosthetic valve to conform to the anatomy of the patient's heart without obstructing other portions of the heart, as will be explained below. Each triangular finger is formed from a pair of interconnected struts. The triangular fingers of the atrial skirt are generally curved radially outward from the central axis of the prosthetic valve and lie in a plane that is transverse to the central valve axis. In some embodiments, the atrial skirt lies in a plane that is substantially perpendicular to the central axis of the valve. The anterior section 802 the atrial apron 806 optionally includes an alignment element 814 one, which may be one or more struts that extend vertically upward and substantially parallel to the prosthetic valve. The alignment element 814 may include X-ray opaque markers (not illustrated) to facilitate fluoroscopic visualization. The alignment element helps the doctor align the prosthetic valve with the anatomy of the native mitral valve, as explained below.

Under the atrial apron area is the anular area 820 arranged, which also has a collapsed configuration for delivery and an expanded configuration for anchoring the prosthetic valve along the native valve annulus. The annular area also comprises a plurality of interconnected struts which form a row of, preferably closed, cells. Seam holes 821 in some of the struts, tissue or other covers (not illustrated) allow attachment to the annular area. Covering all or a portion of the anchor with tissue or other cover helps seal the anchor against the heart valve and adjacent tissue, thereby ensuring that Blood is passed through the valve and not around it. The annular area may be cylindrical, but in preferred embodiments has a posterior section 804 that is circular and an anterior section 802 which is flat, thereby forming a D-shaped cross section. This D-shaped cross-section adapts better to the anatomy of the native mitral valve without obstructing blood flow to other areas of the heart.

The subsection of the prosthetic valve closes the ventricular apron area 828 a. The ventricular apron area also has a collapsed configuration for delivery and an expanded configuration for anchoring. It is formed from a multiplicity of interconnected struts which form a row of cells, which are preferably closed, and which can expand radially. The ventricular apron in the expanded configuration anchors the prosthetic valve to the chamber by expanding against the native mitral valve leaflets. Optional barbs 823 in the ventricular apron can be used to further support the anchoring of the prosthetic valve in the ventricular tissue. Barbs can optionally also be provided in the atrial apron section as well as in the anular region of the anchoring. In addition, optional seam holes can be made 821 may be used in the ventricular apron to aid in the approximation of tissue or other material to the ventricular apron area, as discussed above. The anterior section 802 the ventricular apron can be flat and the posterior section 804 the ventricular apron may be circular, similarly D-shaped in cross-section to anchor and conform to the native anatomy without obstructing other portions of the heart. Also, the lower portions of the ventricular apron serve as insertion control areas because the lower portions can remain shrouded, which restrains the ventricular apron from radial expansion until after the optional ventricular trigonal tabs and posterior tab have been expanded, as explained in more detail below.

The ventricular apron section can optionally also have a few ventricular trigonal tabs 824 include at the anterior portion of the anchor (only one is visible with this intent) to help anchor the prosthetic valve, as explained in more detail below. The ventricular apron can also optionally have a posterior flap 826 on a posterior section 804 the ventricular skirt to anchor the prosthetic valve to a posterior portion of the annulus. The trigonal tabs 824 or the posterior flap 826 are tabs that extend radially outward from the anchor and are inclined upward in the upstream direction.

The actual flap mechanism is made up of three commissure posts (also referred to as commissures) 813 formed, which extend radially inwards in the direction of the central axis of the anchor in a funnel shape or a conical shape. The commissures 813 are formed from a plurality of interconnected struts that create the triangular commissures. The struts of the commissures can have one or more seam holes 821 include which allow tissue or a synthetic material to be attached to the commissures. In this exemplary embodiment, the valve is a tricuspid valve, which is why it has three commissures 813 having. The tips or vertices of the commissures can be a commissure tab 812 (also referred to as a tab) for engaging a delivery catheter. In this embodiment, the tabs have enlarged head regions, which are connected to a narrower neck, which forms a mushroom-like shape. The commissures can be preset to any position, but preferably incline slightly inwards in the direction of the central axis of the prosthetic valve, so that a declining blood flow forces the commissures in apposition to one another to close the valve, and an antegrade blood flow radially adjusts the commissures outside to fully open the door. 8B is a top view showing the prosthetic valve 8A illustrated from the atrial side, and shows the preferred D-shaped cross section.

9A illustrates the prosthetic mitral valve from the 8A to 8B with a cover or cladding 870 attached to sections of anchoring a suture 872 is coupled. This view is from an atrial perspective. In this embodiment, the cover is preferably a pericardium that can come from a number of sources, as disclosed elsewhere in this description. In alternative embodiments, the cover may be a polymer, such as a Dracon polyester, ePTFE, or a synthetic material. The cover is preferably over the annular area 820 and the ventricular apron area 823 arranged and, in some embodiments, the anterior ventricular tabs 824 and the ventricular tab 830 also be covered with the same or a different material. The cover helps seal the anchor against the adjacent tissue so that blood is passed through the valve mechanism. In this embodiment, the atrial apron remains uncovered, just like that Tabs 824 , 830 . In addition, radiopaque markers form 814a a portion of the alignment element and allow visualization of the prosthetic valve under fluoroscopy, which is important during valve alignment.

9B is a perspective view of the prosthetic mitral valve seen from the ventricle shown in 9A you can see. The struts of the valve commissures are covered with the same material or a different material as the annular and ventricular area, as explained above, thereby creating the tricuspid valve leaflets 813 be formed. 9B shows the valve in the closed configuration, in which the three sails are engaged and prevent retrograde blood flow. Commissure tabs 812 remain uncovered and allow the commissures to be coupled to a feeder, as explained below. The prosthetic valve from the 9A to 9B can be sterilized so that it is suitable for implantation in a patient using methods known from the prior art.

10th illustrates the prosthetic valve 9A with the cover removed, and the remaining anchor unrolled and flattened. The prosthetic valve 800 is formed from a plurality of interconnected struts. For example, the atrial apron area closes 806 a plurality of interconnected struts that form a series of vertices and valleys. The flat anterior area 802 the prosthetic valve has its apices and valleys axially offset from those of the remaining portion of the atrial skirt, and this area becomes part of the alignment element 814 . X-ray opaque markers 814a are located on both sides of the offset apex and depressions and help with visualization during the implantation of the valve. An axially aligned connector connects the struts of the apron area 806 with the struts of the annular area 808 . The annular area also includes a plurality of axially aligned and interconnected struts that form apexes and valleys. Connection struts couple struts of the anular area with the struts of the ventricular area 810 . The ventricular area also has a plurality of interconnected struts that form apexes and valleys. In addition, the struts form the sailing commissures 813 who have favourited Ventricular Apron 828 just like the trigonal and posterior tabs 824 , 830 out. Seam holes 821 are arranged along the struts of the annular area as well as the ventricular area to enable attachment of a covering such as pericardium or a polymer such as Dacron or ePTFE. Barbs 823 are along the ventricular apron 828 arranged to help anchor the prosthetic valve to adjacent tissue. Commissure tabs or tabs 812 are at the top of the commissures 813 arranged and can be used to couple the prosthetic valve to a delivery system as explained below. Those skilled in the art will recognize that a variety of strut geometries are used and that strut dimensions, such as length, width, thickness, etc. can also be adapted to anchor with the desired mechanical properties, such as rigidity, radial pressure resistance, commissure deflection , etc. to provide. Therefore, no limitation is intended by the illustrated geometry.

If the flat anchoring structure is formed by EDM, laser cutting, photochemical etching or other techniques known from the prior art, the anchoring is expanded radially to a desired geometry. The anchor is then heat treated using known processes to adjust the shape. Thus, the anchor can be loaded onto a delivery catheter in a collapsed configuration and held in the collapsed configuration with a retention sleeve. Removing the retention sleeve allows the anchor to expand to its relaxed preset shape even. In other embodiments, an expandable member, such as a balloon, can be used to expand the anchor to its preferred expanded configuration.

Feeding systems. The 11-15C show a feed device 1124 designed to transapically deliver a prosthetic mitral valve to the heart. However, those skilled in the art will recognize that the delivery system can be modified and relative movement of the various components can be adjusted to allow the device to be used to deliver a prosthetic mitral valve transseptally. The feeder generally includes a handle 1101 which is the combination of a handle section 1102 and a handle section 1103 (best in 12th can be seen) as well as a flexible tip 1110 , which can penetrate the tip of the heart smoothly, and a sleeve catheter 1109 , which houses a number of additional catheters designed to move axially and are discussed in detail below.

The handle 1101 closes a female Luer thread adapter 1113 one with a Tuohy-Borst adapter 1114 can be used to provide a hemostatic seal for a guide wire, not shown, with a diameter of 0.035 ". The female Luer thread adapter 1113 is with the proximal section of the handle 1101 via a threaded end 1131 (best in 12th to see) in thread contact.

As in 11 to see the handle 1101 a location for the control mechanism that is used to position and insert a prosthetic mitral valve. The handle 1101 provides a housing for a thumbwheel 1106 ready that through a window 1137 can be accessible, which is both on the top and the bottom of the handle 1101 is present. The thumbwheel 1106 grips internally in a threaded insert 1115 (best in 12th to see) one that the sleeve catheter 1109 actuated, and the mechanics of this interaction is explained in detail below.

11 also shows an insert thumb wheel 1104 which is an insertion catheter 1120 (best in 12th to see) provides a linear movement when turning, since the rotating movement of the insert thumb wheel 1104 acts as a drive spindle and the pin 1128 moves forward and distally from the user. The mechanics behind the pen 1128 will be continued below. The thumbwheel lock 1105 provides a safeguard against unwanted rotation of the insertion thumbwheel 1104 ready by acting as a physical barrier against rotation. Around the insert thumb wheel 1104 to rotate, the user must use the thumbwheel lock 1105 push forward what they see from the two slots 1147 (seen in 12th ) in the insert thumbwheel 1105 disengages.

As also in 11 can be seen are a vent valve 1108 and a fluid line 1107 with an internal mechanism in the distal portion of the handle 1101 connected, which is a hemostatic seal for the sleeve catheter 1109 provides. The details of this connection are described below.

The internal mechanics of the feed direction 1114 is detailed in 12th and the following descriptions will disclose the interaction between individual components and the manner in which these components interact to achieve a prosthetic heart valve delivery device.

As in 12th see a section of the handle 1102 and a handle section 1103 together to a handle 1101 to create the base of the feed direction 1124 trains. Around the sleeve catheter 1109 to advance the valve or the sleeve catheter during loading 1109 pull back when inserting a rotating thumbwheel 1106 with a threaded insert 1115 (outer thread 1130 in 13 ) in thread contact (internal thread 1129 , as in 14 to be seen) which moves linearly from a proximal position to a distal position along the axis of the delivery device. The sleeve catheter 1109 is in contact with the threaded insert 1115 and is achieved through the use of a collar or ring 1117 attached, which aligns and connects the collar with the insert. The collar 1117 comes with screws 1116 (best in detail A the 14 to see) on the thread insert 1115 attached and contains a fluid connection 1142 (best in detail A the 14 to see) which is a place for the fluid line 1117 provides so that hemostasis can be maintained between the patient and the delivery device. An o-ring 1118 (best in detail A the 14 see) seals the stationary catheter 1119 (best in 14 to see) against the sleeve catheter 1109 from. The fluid line 1107 also provides a means for visually locating the sleeve catheter 1109 ready for a position while a slot 1138 under control 1101 the fluid line 1107 allows you to use the sleeve catheter during operation 1109 to move (through a hole 1151 , best in detail A the 14 to see), and this shift is clearly visible. To prevent rotation of the threaded insert during the shift, a flat side was created 1164 on both sides of the thread insert 1115 prepared. The flat sides 1164 stay in with the lead 1139 and 1140 in contact, both on the handle section 1102 and the handle section 1103 are arranged so that the protrusions 1139 and 1140 serve the thread insert 1115 grip and prevent rotation. A textured structure 1155 allows the user to use the thumbwheel 1106 easy to rotate in the surgical field. Detents 1141 (best in 14 see) arrange flanges 63 (seen in 14 ) on the thumbwheel 1116 to allow rotation.

The way in which individual catheters (there are four catheters) move in relation to each other is in 12th illustrated. The sleeve catheter 1109 provides a housing for the stationary catheter 1119 ready, which in turn is a housing for the movable hub catheter 1120 provides. The hub catheter 1120 shifts linearly with respect to the nasal catheter 1121 , which can also be moved in relation to any preceding catheter, and the handle 1101 . The stationary catheter 1119 is with a handle section 1103 in an inner hole 1150 connected, which is also a seal between the stationary catheter 1119 and the hub catheter 1120 trains. The distal section of the stationary catheter 1119 is in the form of a bell 1122 (see detail A in 15A) formed which serves as a housing for the hub receptacle 1123 to hold (see in detail A in 15A) .

As previously noted, a thumbwheel lock bends 1105 a rotation of the insertion thumbwheel 1104 in front. To provide a locking force that the thumbwheel lock 1105 holds in a locked position until it is operated, is a spring 1125 in an inner hole 62 recorded (best in 14 to see) and lies on one shoulder 1161 at (best in 14 see) inside the thumbwheel lock 1105 is arranged. That feather 1125 holds the leading edge 1149 the thumbwheel lock 1105 in a locked position in the two slots 1147 the insertion thumbwheel 1104 . A gripping texture 1154 is on the thumbwheel lock 1105 intended for easy operation. To the thumbwheel lock 1105 inside the handle 1101 to arrange and hold is a slot 1135 on both a handle section 1102 as well as a handle section 1103 intended.

As in 12th indicated, is a sliding block 1127 within flat parallel sides 1134 added to the inside of the handle 1101 available. This sliding block 1127 is with the hub catheter 1120 in connection contact and is the physical mechanism that moves the catheter linearly. A feather 1126 is on an external support 1159 mounted and lies on a shoulder 1133 at the distal end of the slide block 1127 is arranged. That feather 1126 forces a pen 1128 (the one inside the through hole 1156 the 14 is arranged) in contact with the proximal edge of an angled slot 1148 that in the insert thumbwheel 1104 is cut. The insert thumb wheel 1104 is between one shoulder 1136 and a snap ring (not shown) added to both features of the handle 1101 are. The gripping texture 1153 on the insert thumb wheel 1104 allows the user to easily turn the thumbwheel clockwise, the pen 1128 to actuate so that this distally along the slot 1148 drives and the sliding block 1127 to move the hub catheter 1120 and the hub 1123 (best in detail A the 15A to see) forward and out of the bell 1122 (can be seen in detail A in 15A) presses. A slit 1132 lies in a handle section 1102 and a handle section 1103 before and prevents the pen 1128 moved beyond a desired area.

A nasal catheter 1121 extends from a Tuohy-Borst adapter 1114 at the proximal end of the handle 1101 and inside through the handle and the respective catheter (sleeve catheter 1109 , stationary catheter 1119 and hub catheter 1120 ) through and ends in the stiff insert 1112 (seen in 15A) the flexible tip 1110 (seen in 15A) that are at the distal end of the sleeve catheter 1109 is present.

13 shows an exploded view of the tip portion of the feeder 1124 and shows the relationship between the prosthetic mitral valve 1165 and the inner and outer catheters. When squeezed and loaded, the prosthetic mitral valve is 1165 between the inner surface of the sleeve catheter 1109 and the outer surface of the nasal catheter 1121 composed. To the prosthetic mitral valve 1165 into the feeder 1124 Three commissure brackets hold and anchor 1160 (circumferentially objected to 120 °) at the proximal end of the prosthetic mitral valve 1165 are provided, contact points between the flap and three slots 1143 (seen in 15A) ready in the outer surface of the hub 1123 are incorporated (spaced at 120 ° in the circumferential direction). After the nasal catheter 1120 ( 15A) by turning the insert thumbwheel 1104 (seen in 12th ) is advanced clockwise, the three commissure tabs 1160 in the three slots 1143 (seen in 15A) be recorded or captured. The hub 1123 can then go to the bell 1122 by releasing the insert thumb wheel 1104 (seen in 12th ) be withdrawn. The prosthetic mitral valve is in this position 1165 on the feeder 1124 anchored and a further squeezing of the valve enables the sleeve catheter 1109 to be pushed over the flap.

The 15A to 15C continue the way in which loading the prosthetic mitral valve 1165 (seen in 13 ) in the feeder 1124 can be reached. First, the flexible tip comes up 1110 on the distal edge 1157 of the sleeve catheter 1109 at. The flexible tip 1110 involves a stiff insert 1112 and a soft and flexible tip section 1111 that on the stiff insert 1112 is sprayed on. The shoulder 1145 and the tapered side 1146 of stiff use 1112 serve the distal edge 1157 of the sleeve catheter 1109 to guide and arrange so that the catheter is on the flexible tip 1110 can rest and be stiffened by this and can be inserted more easily into the tip of the heart.

A starting position from which loading can be reached is in 15A illustrated. As a first step in loading a prosthetic mitral valve 1165 (seen in 13 ) in the feeder 1124 becomes the sleeve catheter 1109 by turning the thumbwheel 1106 withdrawn clockwise. The distal edge 1157 of the sleeve catheter 1109 is retracted until it is at the distal edge of the bell 1122 how in detail A in 15B shown, passing by. As a second step in loading a prosthetic mitral valve 1165 (seen in 13 ) in the feeder 1124 becomes the hub 1123 from under the Bell jar 1122 by turning the insert thumbwheel 1104 (seen in 12th ) advanced clockwise as in detail A in 15C illustrated. The insert thumbwheel can only be turned when the thumbwheel lock 1105 (please refer 12th ) has been set in the forward position, which disengages it from contact with the thumbwheel. Moving the hub 1123 covers three slots 1143 in the three commissure tabs 1160 the prosthetic mitral valve 1165 (seen in 13 ) fit and be anchored. After anchoring the commissure tabs 1160 in the slots 1143 by retracting the hub 1123 A third step to loading a prosthetic mitral valve can be achieved 1165 (seen in 13 ) in the feeder 1124 be carried out. The prosthetic mitral valve 1165 (seen in 13 ) can be squeezed to a minimum diameter by a loading mechanism (not shown) and then the cannula can 1109 to cover the flap by turning the thumbwheel 1106 counter clockwise. The feeder 1124 and the prosthetic mitral valve 1165 are then ready for insertion.

The 16-19B illustrate another exemplary embodiment of a delivery device for transapically implanting a prosthetic valve in a heart. However, one skilled in the art will recognize that the delivery system can be modified and relative movement of the various components changed to enable the device to be used to deliver a prosthesis transseptally. The feeder generally includes a handle 1601 which is the combination of two halves ( 1610 and 1635 ) is just like a tip 1603 , which can penetrate smoothly into the tip of the heart, and a flexible sleeve 1602 , which comprises concentric catheters, which are designed to be axially displaceable and are described in detail below.

The handle 1601 closes a handle cap 1611 one that has a female thread adapter 1612 connects to provide a sealable exit for a 0.035 "diameter guidewire (not shown). The handle cap 1611 is on the handle 1601 with threaded fasteners 1613 appropriate. The female Luer thread adapter 1612 is with the handle cap 1611 via a threaded opening in thread contact, and when fully inserted, it presses against an O-ring ( 1636 , best in 18th seen) against the outside diameter of a guidewire catheter ( 1621 best seen in 18th ) seals.

As in 17th to see the handle 1601 a location for the control mechanism that is used to position and insert a prosthetic mitral valve. The handle 1601 holds a case for a thumbwheel 1616 ready for that through a window 1606 Can be accessed from both the top and bottom of the handle 1601 is present. The thumbwheel 1616 connects with a threaded insert on the inside ( 1627 in 18th ) that the sleeve catheter 1604 actuated, and the mechanics of this interaction is explained in detail below.

17th also shows a first hemostasis tube 1617 that entered the interior through a slit 1605 which is connected to a first hemo connector via a hole ( 1625 respectively. 1626 in 18th ) connects. The first hemostasis tube 1617 allows fluid to be flushed between inner catheters. The position of the first hemostasis tube 1617 along the slot 1605 provides a visual indication of the position of the sleeve catheter 1604 and a relative insertion phase of a prosthetic mitral valve (not shown) ready. The relationship between the connection of the first hemostasis tube 1617 and the sleeve catheter 1604 is described below.

As in 17th you can see a second hemostasis tube 1614 under control 1601 introduced and with a second hemo connector ( 1629 in 18th ) connected to allow fluid to be flushed between internal catheters, and details of this insertion are described below. Finally, a pin lock provides 1608 a safety measure against the premature release of a prosthetic mitral valve by acting as a physical barrier against a shift between internal mechanisms. Pin lock tines 1615 depend on a spring force to lock the pin 1608 in the handle 1601 and a user must first unlock the pin before finally inserting a prosthetic valve 1608 pull out.

17th also shows how the handle 1601 by using threaded fasteners and nuts ( 1607 respectively. 1639 in 18th ) and lowered center holes 1609 held together, which are placed along the length of the handle.

Internal mechanisms of the delivery system are detailed in 18th The following descriptions will disclose the interaction between individual components and the manner in which these components work together to create a system capable of preferentially delivering a prosthetic mitral valve transapically.

As in 18th seen includes the flexible sleeve 1602 four concentrically nested catheters. In the order of The concentrically nested catheters are described in detail from smallest to largest diameter. The innermost catheter is a guiding catheter 1621 that runs inside through the entire feed system, at the top 1603 starting and in the female Luer thread adapter 1612 ending. The guidewire catheter 1621 is composed of a Pebax extrusion with a single lumen and a low durometer or low Shore hardness and is stationary. It provides a channel through which a guidewire (not shown) can communicate with the delivery system. The next catheter is the hub catheter 1622 which is a support for the hub 1620 provides and is generally formed from a PEEK extrusion of higher durometer and with a single lumen. The hub catheter 1622 is with both the hub 1622 at the distal end as well as a stainless steel support rod 1634 mated at the proximal end. The stainless steel support rod 1634 is by means of a stopper 1637 held on to the handle 1601 is bordered. The hub catheter 1622 is stationary and provides support and axial rigidity to the concentrically nested catheter. The next catheter is the bell catheter 1624 which of the hub 1620 provides a housing and generally includes a single lumen medium durometer Pebax extrusion including an inner steel braid and a lubricating liner as well as an X-ray opaque marker tape (not shown). The bell catheter 1624 is axially displaceable and can with respect to the hub 1620 be pushed forward and withdrawn. The bell catheter 1624 is with the second hemo connector 1629 at the proximal end in mating connector and there may be hemostasis between the bell catheter 1624 and the stainless steel support rod 1634 by rinsing the second hemostasis tube 1614 can be achieved. The bell catheter 1624 is at the distal end to a larger diameter 1623 enlarged to the hub 1620 to enclose. The outermost and last catheter is the sleeve catheter 1604 which provides a housing for a prosthetic mitral valve (not shown) and is capable of penetrating the apex (not shown) by inserting a tip 1603 supports and guides and helps with the dilation of an incision in the heart wall muscle. The sleeve catheter 1604 generally includes a single lumen, medium lumen Pebax extrusion, including an inner steel mesh and a lubricating liner, as well as an X-ray opaque marker tape (not shown). The sleeve catheter 1604 shifts axially and can with respect to the hub 1620 be pushed forward and withdrawn. The sleeve catheter 1604 is with the first hemo connection 1625 at the proximal end in mating connection and hemostasis between the sleeve catheter 1604 and the bell catheter 1624 can be done by flushing the first hemostasis tube 1617 can be achieved.

As in 18th the proximal end of the sleeve catheter can be seen 1604 in mating contact with a first hemo connector 1625 . The first hemo connector is in mating contact with a threaded insert 1627 and an O-ring 1638 that is between the first hemo port 1625 and the threaded insert 1627 is caught to against the bell catheter 1624 to press, which creates a hemostatic seal. While the thumbwheel 1616 is rotated, the screw insert moves 1627 and sleeve catheter 1624 can be withdrawn or advanced due to the attachment. In order to provide a suitable stiffness for dilating or dilating the heart wall tissue, the distal edge of the sleeve catheter abuts 1604 against a shoulder 1618 at the top 1603 is arranged. This connection allows the top 1603 , on the sleeve catheter 1604 being secured and aligned during feeding and creates a rigidity.

18th also describes in more detail the mechanism by which the bell catheter operates 1624 in terms of the hub 1620 can be withdrawn or advanced. The thumbwheel 1616 can be rotated to the extent that the screw insert 1627 with two pens 1628 which is brought into contact in the second hemo connector 1629 are pressed in. During the bell catheter 1624 with the second hemo connector 1629 in opposite contact causes the thumbwheel to turn further 1616 that the second hemo connector 1629 moves and due to a connection with a second hemo connection cap 1632 against a feather 1633 presses. This advancement causes the diameter section to increase in diameter 1623 of the bell catheter 1624 from the hub 1620 is withdrawn. While the thumbwheel 1616 rotated in the opposite direction causes one by the spring 1633 restored restoration force that the second hemo connector 1629 is pushed in the opposite direction, causing the enlarged diameter section 1623 of the bell catheter 1624 back over the hub 1620 pulls, a process that is necessary during the initial loading of a valve prosthesis.

18th further describes in more detail the manner in which hemostasis between the stainless steel support rod 1634 and bell catheter 1624 is achieved. An o-ring 1631 is between the second hemo connector 1629 and the second hemo cap 1632 compressed what a seal against the stainless steel support rod 1634 creates. Hemostasis between the bell catheter 1624 and the stainless steel support rod 1634 can be done by rinsing the second hemostasis tube 1614 can be achieved, which is connected to the cavity to be flushed through a slot and a hole.

The deployment process and actions that are necessary to activate the mechanisms responsible for deployment are described in the 19A-19B described in more detail. If carried out in reverse order, these actions are also necessary for the first loading of a valve (not shown) before the intervention.

As in 19A can be seen represents manipulation of the thumbwheel 1616 a displacement control of the sleeve catheter 1604 ready. To effect the insertion of a heart valve (not shown), the user must use the sleeve catheter 1604 from contact with the shoulder 1618 the top 1603 pull back until it is at the larger diameter section 1623 of the bell catheter 1624 passes by. A heart valve (not shown) is concentric over the guidewire catheter 1621 in the position indicated by the dash for 1621 in 19A , similar to the one in 13 illustrated embodiment. The sleeve catheter 1604 can be withdrawn until the screw insert 1627 with the pin lock 1608 comes into contact. The pin lock 1608 must then be removed before further movement of the screw insert 1627 can be reached.

As in 19B will see the pin lock 1608 from the handle 1601 removed for further displacement of the sleeve catheter 1604 to enable. If the sleeve catheter 1604 is completely withdrawn, is also the section of larger diameter 1623 of the bell catheter 1624 fully withdrawn, which completely frees the heart valve (not shown) from the delivery system. Three hub slots 1619 which are circumferentially spaced 120 ° apart provide the anchoring mechanism and the physical connection between the delivery system and the heart valve. As soon as the section of larger diameter 1623 of the bell catheter 1624 has been withdrawn, the hub slots 1619 uncovered, which allows the heart valve anchorage (not shown) to expand fully.

20th illustrates a distal portion of the delivery device 16 . Three hub slots 1619 are large in diameter relative to the tip 1623 of the bell catheter 1624 arranged distally displaceable. These slots allow engagement with a prosthetic valve. The flap can be detached through the slots by arranging the commissure tabs or tabs 812 the prosthetic valve in slots 1619 and then pulling back the slots 1619 under the top 1623 of the bell catheter 1624 be held releasably. The prosthetic valve can be moved by distally displacing the slots relative to the bell catheter 1624 are released from the delivery catheter so that the loading anchor or tabs 812 out and away from the slots 1619 can expand if the restriction of the top 1623 on the bell catheter 1624 has been removed.

21 illustrates a prosthetic mitral valve 800 (as above with reference to 8A explained) with the anchoring tabs 812 , which are arranged in the hub slots (not visible) and the bell catheter 1624 pushed over it. Although most of the prosthetic valve 800 even when expanded to its expanded configuration, the valve commissures remain in a collapsed configuration with the tabs 812 in the slots 1619 added. Once the bracket is through the bell catheter 1624 is provided by the slots 1619 the tabs can be removed 812 even out of the slots 1619 expand and the commissures will open to their default position. The prosthetic valve is then decoupled from the feed device and released.

Transapical feeding procedure. The 22A to 22G illustrate an exemplary method for transapical delivery of a prosthetic mitral valve. This embodiment can use any of the prosthetic valves described herein and can use any of the delivery devices described herein. 22A illustrates the transapical path through entry into the heart at the apex 2202 , through the left chamber 2204 , over the mitral valve 2206 and in the left atrium 2208 is taken. The aortic valve 2210 remains unaffected. Transapical delivery methods have been described in the patent and scientific literature, such as in PCT International Publication No. WO2009 / 134701 whose entire content is hereby incorporated by reference.

In 22B becomes a feeder 2214 through an incision in the apex 2202 and through a guidewire GW through the chamber 2204 , on the mitral valve 2206 over, with a distal portion of the delivery device 2214 in the atrium 2208 arranged, introduced. The feeder has a rounded tip 2212 which is set up to go through and widen the incision and can pass through the heart without causing unwanted trauma to the Mitral valve 2206 or adjacent tissue. A seam 2216 can around the feeder 2214 at the apex 2202 by using a tobacco pouch suture or other pattern known in the art to prevent excessive bleeding and to help hold the delivery device in place.

In 22C is the outer sleeve 2214a the feed device 2214 in the proximal direction relative to the prosthetic mitral valve 2220 withdrawn (or the prosthetic mitral valve is distal relative to the outer sleeve 2214a advanced) to the alignment element 2218 and a portion of the atrial apron area 2222 on the prosthetic mitral valve 2220 to expose what the atrial apron area 2222 allows to expand and expand partially radially outwards. The alignment element 2218 can have a few radiopaque markers 2218a include that facilitate visualization by fluoroscopy. The doctor can align the alignment element so that the X-ray opaque markers 2218a are located on each side of the anterior mitral valve leaflet. The feeder 2214 can be rotated to help align the alignment element. The alignment element is preferably located adjacent to the aortic root and between the trigona fibrosa of the native anterior sail.

Once the alignment has been achieved, the sleeve will 2214a in 22D further retracted in the proximal direction, causing a radial expansion of the atrial skirt 2222 that widens outward to form a flange. Proximal withdrawal of the delivery device 2214 and the prosthetic valve 2220 sets the atrial apron 2222 against an atrial surface attached to the mitral valve 2206 adjoins, which anchors the prosthetic valve in a first position.

22E shows a further proximal withdrawal of the sleeve 2214a an additional limitation from the prosthetic valve 2220 releases and axially removes, allowing the flap to expand itself further. The annular area 2224 expands into engagement with the mitral valve annulus and the ventricular trigonal tabs 2226 and the posterior flap 2228 expands radially. Portions of the ventricular apron serve as deployment control areas and prevent expansion of the entire ventricular apron as they continue to be held. The tabs are captured between the anterior and posterior mitral valve leaflets and the ventricular wall. The posterior ventricular anchor tab 2228 is preferably aligned in the middle of the posterior mitral valve panel where there is no chord attachment and is slid over the posterior panel to sit between the posterior panel and the ventricular wall or heart wall. The two ventricular trigonal anchor tabs 2226 are positioned on each side of the anterior sail with their heads positioned at the Trigona Fibrosa. A slight rotation and realignment of the prosthesis can take place at this time. As the prosthesis expands, the anterior trigonal tabs anchor to the Trigona Fibrosa, accommodate the native anterior sail and chordae between the tabs and the anterior surface of the prosthetic valve, and the posterior ventricular tab anchors between the ventricular wall and the posterior sail , which captures the posterior sail between the posterior anchor tab and the posterior surface of the prosthetic valve assembly.

22F shows that further withdrawal of the sleeve 2214a the ventricular trigonal tabs and the posterior tab releases, and that the insertion control areas of the ventricular apron 2230 are also released and allowed to expand radially outward against the native mitral valve leaflets. This creates a sealing funnel in the native sails and helps direct blood flow through the prosthetic mitral valve. With the commissures of the prosthesis still included in the delivery system, very small adjustments can continue to be made to ensure accurate positioning, anchoring and sealing. The prosthetic valve is now anchored in four positions. The anchoring tabs 2232 are then released from the delivery device by retracting an inner shaft, allowing the tabs to expand on their own from the slots on the delivery catheter, as described above and in FIG 22G shown. The prosthetic valve is now implanted in the patient's heart, and the native mitral valve takes over. The feeder 2214 can be removed from the heart by withdrawing it proximally and removing it from the apex incision. The seam 2216 can then be sewn, which seals the puncture point.

Transseptal delivery procedures. The 23A to 23G illustrate an exemplary method for transseptal delivery of a prosthetic mitral valve. This embodiment can use any of the prosthetic valves described herein and can use any of the delivery devices described herein if modified accordingly. Those skilled in the art will recognize that relative movement of the various shafts in the delivery system embodiments disclosed above must be reversed to achieve one to enable transseptal approach. 23A illustrates the general transseptal path that leads up the vena cava 2302 to the right atrium with the delivery device 2304 is taken. A transseptal puncture 2306 is created by the atrial septum, often by the oval foramen, so that the device is in the left atrium 2308 , over the mitral valve 2310 and adjacent to the left chamber 2312 can be performed. Transseptal techniques have been described in patent and scientific literature, such as, for example, US Patent Publication No. 2004/0181238 by Zarbatany et al. Published, the entire content of which is incorporated here by reference.

In 23B becomes a feeder 2314 via a lead wire GW through the vena cava 2302 into the right atrium 2306 guided. The feeder 2314 then becomes transseptal through the atrial wall into the left atrium 2308 adjacent to the mitral valve 2310 guided. The guidewire GW can be placed over the mitral valve 2310 led in the left chamber 2312 to be ordered. The distal tip of the delivery device typically includes a nasal cone or other atraumatic tip to prevent damage to the mitral valve or adjacent tissue.

In 23C becomes the outer sleeve 2214a the feed device 2214 in the proximal direction relative to the prosthetic mitral valve 2319 withdrawn. Alternatively, a distal section 2314b the feed device 2214 in the distal direction relative to the prosthetic valve 2319 be advanced to the alignment element 2316 and a portion of the atrial apron area 2318 on the prosthetic mitral valve 2319 to expose what enables the atrial apron area 2318 begins to expand and expand partially radially outwards and outwards. The alignment element 2316 can have a few radiopaque markers 2316a which facilitate visualization by fluoroscopy. The doctor can then align the alignment element so that the X-ray opaque markers 2316a , are located on each side of the anterior mitral valve leaflet. The alignment element is preferably arranged adjacent to the aortic root and between the Trigona Fibrosa of the native anterior sail. The feeder 2214 can be rotated to help align the alignment element.

Once alignment has been achieved, the distal section 2314b in 23D advanced further distally, causing a radial expansion of the atrial apron 2318 allows that widens outwards to form a flange. A distal advance of the delivery device 2214 and the prosthetic valve 2319 sets the atrial apron 2318 against one on the mitral valve 2310 adjacent atrial surface, which anchors the prosthetic valve in a first position.

23E shows that distal advancement of the distal section 2314b an additional limitation of the prosthetic valve 2319 exposed and axially removed, thereby allowing more of the valve to expand itself. The annular area 2320 expands into engagement with the mitral valve annulus and the ventricular trigonal tabs 2324 and the posterior flap 2322 expand radially. Portions of the ventricular apron serve as insertion control areas because they are retained and therefore the entire ventricular apron cannot expand. The tabs are captured between the anterior and posterior mitral valve leaflets and the ventricular wall. The posterior ventricular anchor tab 2322 is preferably aligned in the middle of the posterior mitral valve panel where there is no chord attachment and is passed over the posterior panel to sit between the posterior panel and the ventricular wall. The two ventricular trigonal anchor tabs 2324 are positioned on either side of the anterior sail with their heads positioned at the Trigona Fibrosa. A slight rotation and realignment of the prosthesis can take place at this time. As the prosthesis expands, the anterior trigonal tabs anchor to the Trigona Fibrosa, capturing the native anterior sail and chordae between the tabs and the anterior surface of the prosthetic valve, and the posterior ventricular tab anchors between the ventricular wall and the posterior sail what the posterior sail picks up or captures between the posterior anchor tab and the posterior surface of the prosthetic valve assembly.

23F shows that distal advancement of the distal section 2314b releases the ventricular trigonal tabs and the posterior tab and the ventricular apron 2326 also released and allowed to expand radially outward against the native mitral valve leaflets without engaging the ventricular wall. This creates a sealing funnel in the native sails and helps direct blood flow through the prosthetic valve. With the commissures of the prosthetic valve still taken up by the delivery system, small adjustments can still be made to ensure accurate positioning, anchoring and sealing. The prosthetic valve is now anchored in four positions. The anchoring tabs 2328 are then released from the feeder by further advancing an inner shaft, allowing the tabs to come out even from the slots on the Expand delivery catheter as described above and in 23G shown. The prosthetic valve is now implanted in the patient's heart and takes over the native mitral valve. The feeder 2314 can then be removed from the heart by withdrawing them proximally through the atrial septum and out of the vena cava.

24th shows the prosthetic valve 2418 anchored in the mitral space after transapical or transseptal delivery. The prosthetic valve 2418 is preferred the in 8A illustrated mitral valve and was shown by the in the 22A to 22G or that 23A to 23G shown method supplied. The prosthetic valve 2418 is itself radially expanded into engagement with the mitral valve to anchor it in place without other portions of the heart, including the left ventricular outflow tract, such as the aortic valve 2402 to hinder. The anterior trigonal tabs 2408 (only one can be seen in this view) and the posterior ventricular flap 2405 are relative to the rest of the ventricular apron 2410 expands radially outwards and the anterior sail 2406 and the posterior sail 2404 are between the flap or the ventricular apron 2410 added to form an anchor point. The ventricular apron 2410 is also expanded radially outward to engage and push out at least some of the tendon chordae and papillary muscles, but preferably without pushing against the ventricular wall. The annular area 2416 is expanded radially outward to engage and press the mitral valve annulus and the atrial apron 2414 is also expanded outward to form a flange that rests on the atrium above the mitral valve. This is the prosthetic valve 2418 anchored at four positions in the mitral space, which prevents the prosthetic valve from migrating or being removed during a contraction of the heart. In addition, the use of four anchoring points reduces the anchoring pressure that must be applied in each existing anchoring zone compared to a prosthesis that is anchored in only a single anchoring zone or in any combination of these four anchoring zones. The consequent reduction in radial force that must be exerted against the native structures in each zone minimizes the risk of collision with the nearby aortic valve or aortic root caused by the relocation of the native mitral valve leaflet. The flap sail 2420 form a tricuspid valve that opens in antegrade blood flow and closes in retrograde blood flow. The tab 2412 at the top or top of the commissures 2421 (best in 25th can be seen) remains free of the feed device after the disengagement.

25th illustrates the prosthetic valve 2418 out 24th anchored in the mitral space and viewed from the left ventricle, looking up towards the atrium. As mentioned earlier, the prosthetic valve can 2418 transapically or transseptally and is preferably the in 8A illustrated prosthetic mitral valve, which is shown in the 22A to 22G or in the 23A to 23G shown method has been supplied. This view more clearly illustrates the anchoring and engagement of the prosthetic mitral valve 2418 with the adjacent tissue. For example, the three flap sails 2420 which form the tricuspid valve shown in the open position which allows blood to flow past it. In addition, the anterior trigonal tabs are 2408 and the posterior ventricular flap 2405 in an engagement with the ventricular heart tissue 2425 shown expanded radially outwards. The anterior section of the prosthetic valve between the anterior trigonal tabs 2408 is approximately flat to match the corresponding flat anatomy, as stated above. The flat shape of the anterior portion of the prosthetic valve prevents collision and obstruction of adjacent anatomy through the prosthetic anatomy through the prosthetic valve, such as the left ventricular outflow tract including the aortic valve. 25th also illustrates how the ventricular apron 2410 expanded radially outward against the native mitral valve leaflets.

Drug delivery. Any of the prosthetic valves can also be used as an agent delivery device for local agent elution. The therapeutic agent can coat the prosthetic valve, the anchoring covering tissue, or both, or otherwise carried through the prosthetic valve and eluted therefrom after implantation. Exemplary drugs include calcification inhibitors, antibiotics, platelet aggregation inhibitors, anti-inflammatory drugs, drugs that inhibit tissue rejection, restino inhibitors, thrombosis inhibitors, thrombolytics, etc. Medicaments which have these therapeutic effects are known to the person skilled in the art from the prior art.

Although the exemplary embodiments have been described in detail for clarity of understanding and by way of example, a variety of additional modifications, adaptations and changes will be apparent to those skilled in the art. Those skilled in the art will recognize that the herein described different features can be combined or replaced. Accordingly, the scope of the present invention is limited only by the appended claims.

QUOTES INCLUDE IN THE DESCRIPTION

This list of documents listed by the applicant has been generated automatically and is only included for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• US 2008054410 PCT [0006]
• WO 2008/103722 [0006]
• US 2009041754 PCT [0007]
• WO 2009/134701 [0007, 0098]
• US 2007/0016286 [0008]
• US 6629534 [0009]
• US 2011/0015731 [0010]

Claims (16)

A delivery system (1124) for delivering a prosthetic heart valve (10; 800) to a patient's heart, the prosthetic heart valve (10; 800) having an anchor (16) having a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the has a prosthetic heart valve (10; 800) on the patient's heart and a commissure post (24; 813) with a commissure flap (812), the delivery system (1124) a hub shaft (1622) with a slot (1619) for receiving the commissure flap (812) of the prosthetic heart valve (10; 800); a bell shaft (1624) slidably and concentrically disposed over the hub shaft (1622) to cover the slot (1619) of the hub shaft (1622); and a sleeve (1604) slidably and concentrically disposed over the bell stem (1619) to receive the prosthetic heart valve (10; 800) in the collapsed configuration; wherein the prosthetic heart valve (10; 800) can expand independently into engagement with the patient's natural cardiac tissue by withdrawing the sleeve (1604) while the commissure flap (812) is still trapped in the slot (1619) of the hub shaft (1622); and wherein the commissure flap (812) can expand independently of the slot (1619) by pulling back the bell shaft (1624) in order to completely release the prosthetic heart valve (10; 800) from the delivery system (1124). Feed system (1124) after Claim 1 wherein the delivery system (1124) has a handle (1601) proximate a proximal end of the delivery system (1124), the handle (1601) including an actuation mechanism configured to engage the bell shaft (1624) and the sleeve (1604 ) to advance and withdraw. A delivery system (1124) for delivering a prosthetic heart valve (10; 800) to a patient's heart, comprising a hub shaft (1622); a bell shaft (1624) slidably and concentrically disposed over the hub shaft (1622); a sleeve (1604) slidably and concentrically disposed over the bell stem (1624); and a handle (1601) with an actuating mechanism which is designed to advance and retract the bell shaft (1624) and the sleeve (1604). Feed system (1124) after Claim 2 or 3rd wherein the actuating mechanism includes a rotatable wheel (1616) for retracting the bell stem (1624) and the sleeve (1604). Feed system (1124) after Claim 4 , further comprising a first element, preferably a first hemo connector (1625), and a threaded insert (1627), the sleeve (1604) being in mating connection with the first element (1625) and the first element (1625) in mating contact with the threaded insert (1627), the threaded insert (1627) moving linearly and the sleeve (1604) being retractable and retractable when attached when the rotatable wheel (1616) is rotated; and a second element, preferably a second hemo connector (1629) with two pins (1628), which are provided by means of an interference fit in the second hemo connector (1629), which is in suitable contact with the bell shaft (1624), and a spring ( 1633), further rotation of the rotatable wheel (1616) bringing the threaded insert (1627) into contact with the second element, preferably the two pins (1628), causing the second element (1629) to move linearly and pressing against the spring (1633) to retract the bell shaft (1624) from the hub shaft (1622), a restoring force generated by the spring (1633) causing the second member (1629) to move in the opposite direction to be pressed, whereby the bell shaft (1624) is pushed back over the hub shaft (1622) when the rotatable wheel (1616) is rotated in the opposite direction. Feed system (1124) according to one of the preceding claims, wherein the hub shaft (1622) has three slots (1619) which are arranged at a distance of approximately 120 ° from one another in the circumferential direction. A delivery system (1124) according to any one of the preceding claims, further comprising an inner guide wire shaft (1621) with a cavity extending therethrough, the cavity being adapted to slidably receive a guide wire, the hub shaft (1622) concentrically above the inner guide wire shaft (1621 ) is arranged. A prosthetic heart valve (10; 800), comprising: an anchor (16) having a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic heart valve (10; 800) to a patient's heart; and a prosthetic valve leaflet (14) coupled to the anchor, the prosthetic valve leaflet (14) being coupled to a commissure post (24, 813) having a commissure tab (812), which is designed to releasably couple the commissure post (24; 813) to a feed system (1124); wherein the prosthetic heart valve (10; 800) is arranged to independently expand into engagement with the natural heart tissue of the patient, while the commissure post (24; 813) of the prosthesis (10; 800) is still captured by the delivery system (1124), whereby a sealing funnel is preferably formed within the natural valve leaflets and the natural valve leaflets are pushed away from the prosthetic commissure post (24; 813) in order to prevent a blockage of the prosthetic valve function; and to be fully released from the delivery system (1124) by releasing the commissure post (24; 813). Prosthetic heart valve (10; 800) after Claim 8 , wherein the commissure strap (812) is arranged at the tip of the commissure post (24; 813) and preferably has an enlarged head region which is connected to a narrower neck, as a result of which a mushroom-like shape is formed. Prosthetic heart valve (10; 800) after Claim 8 or 9 The anchor has three commissure posts (24, 813), which are preferably angled inward in the direction of the central axis of the prosthetic valve (10; 800), so that the commissure posts (24; 813) are forced into apposition by retrograde blood flow in order to to close the flap (10; 800), and so that the commissure posts (24; 813) are pressed radially outward by antegrade blood flow in order to open the flap (10; 800) completely. Prosthetic heart valve (10; 800) after Claim 8 , 9 or 10th , wherein the prosthetic heart valve (10; 800) has three valve leaflets (14) which have a tricuspid sail configuration. Prosthetic heart valve (10; 800) after Claim 10 and 11 , wherein the commissure posts (813) have a triangular shape and the flap sails (14) are attached to the commissure posts (813) along curved seams (28). Prosthetic heart valve (10; 800) according to one of the Claims 8 to 12th wherein at least a portion of one or more prosthetic valve leaflets (14) comprises tissue or a synthetic material. Prosthetic heart valve (10; 800) according to one of the Claims 8 to 13 wherein the armature (16) has a D-shaped cross section in the expanded configuration. Prosthetic heart valve (10; 800) according to one of the Claims 8 to 14 , wherein the anchor is made of a self-expanding material, preferably nitinol. Arrangement with a feed system (1124) according to one of the Claims 1 to 7 and a prosthetic heart valve (10; 800) according to one of the Claims 8 to 15 .

Images